Last updated on March 2010

Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children: a Randomised Double-blind Placebo-controlled Study


Brief description of study

Viral upper respiratory tract infection (URI) is one of the most common diseases among toddlers and pre-school children.Complete and effective prevention measures for URI are currently unavailable. Montelukast (Singulair ) is a selective leukotriene-receptor antagonist that inhibits the cysteinyl leukotriene 1 receptor. It is well tolerated and safe even in young children. Montelukast is an effective treatment for asthma (and allergic rhinitis from 1 year of age. Infections with viruses causing URI such as Influenza A, Rhinovirus and respiratory syncitial virus increases leukotriens levels in nasal secretions. Therefore, one may postulate that leukotriens inhibitors may reduce symptoms during URI. However the effect of montelukast as a treatment for non-specific cough was not properly studied and there are no studies on the effect of montelukast as prevention for URI. Hypothesis: Prophylactic treatment with Montelukast will reduce the incidence and severity of upper respiratory infection in children.

Clinical Study Identifier: NCT00551382

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Al Garushi, MD

Kupat Cholim Clalit
Lod, Israel
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Zachi Lotem

Kupat Cholim Clalit
Ramla, Israel
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Mati Berkovitch, MD

Assaf Harofeh
Zerifin, Israel
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